Clinical Research Associate
Company: GSK
Location: Jacksonville
Posted on: April 8, 2021
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Job Description:
** We are seeking candidates from Florida - Miami, Orlando,
Tampa Or Jacksonville Are you interested in a clinical research
role that leverages your expertise in clinical trial site
coordination? If so, this Clinical Research Associate role could be
an ideal opportunity to explore. As a Clinical Research Associate
(CRA), you will manage/lead/be responsible for focusing on the
coordination of all activities required to evaluate, initiate,
monitor and close clinical trial sites in accordance with
regulations. This role will provide YOU the opportunity to lead key
activities to progress YOUR career. These responsibilities include
some of the following : --- Perform all site development, site
set-up, site monitoring, and site close-out activities for specific
clinical trial investigator sites in accordance with customer
expectations, GSK operating standards, and good clinical
practices.--- Ensure the protection of study patients by verifying
that informed consent procedures and protocol requirements are
adhered to according to the applicable regulatory requirements---
Supports and implements Risk Based Monitoring as directed.---
Evaluates the Risk Signals of KRIs along with existing knowledge
and experience of investigator sites to support appropriate
monitoring intervention, frequency of intervention and areas to
focus on during intervention--- Participates in study team
activities, such as PM lead, reviewer for study documents, user
acceptance testing, and all activities requiring the input of
CRAs.--- Contributes to Investigator meetings by presenting topics
or managing interactive sessions with investigator site staff.---
Reports out on audit findings, and corrective actions as lessons
learned.--- Assist in developing the field monitoring organization
characterized by process standardization, best practice sharing,
and continuous improvement.--- Function as the primary site contact
between the site staff (i.e., Principal Investigator, Study
Coordinator) and GSK. Cultivates and maintains strong working
relationships and communication with investigators and GSK
staff.--- Assume a greater leadership role in the development and
implementation of efficient and effective approaches to study site
management (e.g. training co-workers and/or contract monitors;
coaching/mentoring monitoring colleagues and study staff, as
appropriate;--- Provides training, delegated by the Monitoring
Manager, for new monitoring personnel and contributes to their
performance appraisals, as appropriate.--- Acts as a resource for
other monitoring personnel regarding study-specific knowledge, as
well as monitoring issues.--- Assist with training of all site
personnel through established formal channels when deemed
essential--- Takes a leadership role within monitoring organization
through assisting with clinical projects, as appropriate.---
Represents US Monitoring / Global Clinical Operations on internal
and external process improvement teams. Takes leadership role when
participating in process teams on behalf of the Monitoring
organization.--- Independently completes special projects as
assigned by Monitoring management.--- Performs the following
routine clinical trial site monitoring functions:- Monitor
compliance with study protocol, CFR, GCP/ICH and overall clinical
objectives.- Ensure clinical trial site training records are
current and maintained as required.- Verify adequacy of clinical
data through comparison of case report forms to source documents.-
Perform CRF review, query generation and resolution against
established data review guidelines- Confirms appropriate management
of investigational product by performing drug reconciliation and
accountability and other related activities.- Confirms all elements
of lab assessment are conducted according to guidelines and
standards.- On-going review of site regulatory file for
completeness and accuracy.- Implement any new activities, instream,
as defined by the study team to ensure compliance of protocol
activities at site level- Track and report progress of study,
including patient enrollment/screening, data monitoring, protocol
variations, issue resolution, and follow up compliance, subject
safety and data quality.- Prepare and submit visit trip reports,
GCP Checklists and follow up letters within timelines outlined in
the Clinical Monitoring Plan. --- Assist with development of
clinical trial specific documents such as Monitoring Plan, CRF
Completion Guidelines, etc.--- Manage multiple timelines/deadlines
to meet study milestones.--- Participate in Quality Plan
activities, including management of activities to ensure quality
outcomes.Why you?Basic Qualifications: We are looking for
professionals with these required skills to achieve our goals: ---
Bachelors Degree in Life Science or professional degree in life
science/ medical background/equivalent expertise.--- A minimum of 5
years of relevant experience working on clinical trials.--- Travel,
including air travel is an essential function of the job up to 80%.
Travel external to assigned region is expected when other regions
require support.--- Valid drivers licensePreferred
Qualifications:If you have the following characteristics, it would
be a plus: --- 2-3 years monitoring experience in clinical trials
is preferable.--- Consistently displays excellence in communication
skills of a top level CRA.--- CRA role requires understanding of
medical and scientific concepts and language in order to
effectively interpret protocol requirements, understand medical
notes and effectively conduct monitoring activities.--- CRA role is
complex and requires the ability to balance multiple competing
priorities, stakeholders and timelines. Familiarity with the basic
language and process of sponsored clinical research is required. In
addition, knowledge of ICH-GCP and local regulations is critical
for success in this role.--- Increased complexity of allocated
studies, increased autonomy and requirement to contribute to
process improvement requires significant level of expertise in core
role.--- Exhibits ability to identify and interpret problems,
recommend creative solutions, and influence appropriate changes.---
Demonstrates diligent and self-motivated approach to working in an
off-site and independent working environment.--- Demonstrates above
average ability to effectively manage multiple priorities and
responsibilities of increasing scope and complexity.--- Exhibits
enhanced awareness of site dynamics and demonstrates ability to
motivate, persuade, and educate site personnel.Why GSK?Our values
and expectations are at the heart of everything we do and form an
important part of our culture. These include Patient focus,
Transparency, Respect, Integrity along with Courage,
Accountability, Development, and Teamwork. As GSK focuses on our
values and expectations and a culture of innovation, performance,
and trust, the successful candidate will demonstrate the following
capabilities: --- Operating at pace and agile decision-making using
evidence and applying judgement to balance pace, rigour and
risk.--- Committed to delivering high quality results, overcoming
challenges, focusing on what matters, execution.--- Continuously
looking for opportunities to learn, build skills and share
learning.--- Sustaining energy and well-being.--- Building strong
relationships and collaboration, honest and open conversations.---
Budgeting and cost-consciousness. *LI-GSK *This is a job
description to aide in the job posting, but does not include all
job evaluation details. If you require an accommodation or other
assistance to apply for a job at GSK, please contact the GSK
Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155
(outside US). GSK is an Equal Opportunity Employer and, in the US,
we adhere to Affirmative Action principles. This ensures that all
qualified applicants will receive equal consideration for
employment without regard to race, color, national origin,
religion, sex, pregnancy, marital status, sexual orientation,
gender identity/expression, age, disability, genetic information,
military service, covered/protected veteran status or any other
federal, state or local protected class. Important notice to
Employment businesses/ Agencies GSK does not accept referrals from
employment businesses and/or employment agencies in respect of the
vacancies posted on this site. All employment businesses/agencies
are required to contact GSK's commercial and general
procurement/human resources department to obtain prior written
authorization before referring any candidates to GSK. The obtaining
of prior written authorization is a condition precedent to any
agreement (verbal or written) between the employment business/
agency and GSK. In the absence of such written authorization being
obtained any actions undertaken by the employment business/agency
shall be deemed to have been performed without the consent or
contractual agreement of GSK. GSK shall therefore not be liable for
any fees arising from such actions or any fees arising from any
referrals by employment businesses/agencies in respect of the
vacancies posted on this site. Please note that if you are a US
Licensed Healthcare Professional or Healthcare Professional as
defined by the laws of the state issuing your license, GSK may be
required to capture and report expenses GSK incurs, on your behalf,
in the event you are afforded an interview for employment. This
capture of applicable transfers of value is necessary to ensure
GSKs compliance to all federal and state US Transparency
requirements. For more information, please visit GSKs Transparency
Reporting For the Record site.
Keywords: GSK, Jacksonville , Clinical Research Associate, Healthcare , Jacksonville, Florida
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